pan-Canadian Pharmaceutical Alliance (pCPA): October 2021 Trends and Insights
October 2021 Highlights:
- 3 products completed CADTH review
- 6 products initiated pCPA negotiations
- 8 negotiations were completed with an LOI
- 0 negotiation were closed without an LOI
- 0 file were closed without negotiation
Key Take-Aways:
- The volume of files under consideration has decreased steadily over the past three months from 37 in August to 31 as of October 31st. However the average time under pCPA consideration increased to its highest point in 2021 (175 days). Abecma, the fourth CAR-T cell cancer therapy reviewed by CADTH, received a ‘Do Not Reimburse’ recommendation.
- While the pCPA initiated negotiations for 6 products in October, the total number of files under active negotiation decreased for the third month in a row (33) as a result of 8 negotiations concluding with an LOI.
- The pCPA initiated negotiations on the same day for Jorveza for 2 different but closely related indications, one of which had been under consideration for 359 days, signalling that pCPA likely waited for both indications to have CADTH recommendations to engage at once.
- The pCPA concluded 8 negotiations with an LOI in October, consisting of 1 non-oncology file, 4 oncology files, 2 biosimilars, and 1 gene therapy. The biosimilars (rituximab and bevacizumab) are both the fourth versions to have concluded pCPA negotiations. The oncology product Calquence completed two negotiations for similar indications under identical timelines (131 days) while their CADTH recommendations were separated by 2 months.
- The overall volume and average negotiation time of files continues to trend at levels seen throughout most of 2021.
Files Under pCPA Consideration*:
CADTH issued 3 new recommendations in October (31 files under pCPA consideration as of October 31st – down from 34 in September).
| PRODUCT | INDICATION | SPONSOR | Reimbursement Recommendation | REC’N* DATE |
|---|---|---|---|---|
| Non-Oncology | ||||
| None | ||||
| Oncology | ||||
| Onureg (azacitidine) | Acute myeloid leukemia | Celgene Inc. | Conditional Reimbursement | 2021-10-01 |
| Keytruda (pembrolizumab) | Classical Hodgkin lymphoma | Merck Canada Inc. | Conditional Reimbursement | 2021-10-18 |
| Abecma (idecabtagene vicleucel)** | Multiple myeloma | Celgene Inc. | Do Not List/Do Not Reimburse | 2021-10-27 |
*Note: MORSE defines “Rec’n date” as the time of‘final recommendation issued to sponsor and drug plans’, and the ‘Time to Initiate’ as the time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’.
**Cell and gene therapy
*Note: that files that initiated pCPA negotiation prior to receiving a CADTH recommendation were excluded from the under-consideration timeline analysis
Signals Decoded:
The volume of files under consideration has decreased steadily over the past three months from from 37 in August to 31 as of October 31st. However the average time under pCPA consideration increased to its highest point in 2021 (175 days). Abecma, the fourth CAR-T cell cancer therapy reviewed by CADTH, received a ‘Do Not Reimburse’ recommendation.
Negotiation Initiation:
The pCPA initiated 6 new negotiations in October bringing the number of active negotiations to 33 (as of October 31st), down from 35 in September.
| PRODUCT | INDICATION | SPONSOR | INITIATE DATE | TTI* |
|---|---|---|---|---|
| Non Oncology | ||||
| Ruzurgi (amifampridine) | Lambert-Eaton myasthenic syndrome | Médunik Canada Inc. | 2021-10-18 | 181 |
| Jorveza (budesonide) | Maintenance of Eosinophilic esophagitis in adults | AVIR Pharma Inc. | 2021-10-22 | 78 |
| Jorveza (budesonide) | Eosinophilic esophagitis, adults | AVIR Pharma Inc. | 2021-10-22 | 359 |
| Oncology | ||||
| Imfinzi (Durvalumab) | Extensive-stage small cell lung cancer | AstraZeneca Canada Inc. | 2021-10-21 | 104 |
| Alunbrig (Brigatinib) | Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer | Takeda Canada Inc. | 2021-10-29 | 176 |
| Opdivo & Yervoy (Nivolumab & Ipilimumab in combo) | Malignant Pleural Mesothelioma (MPM) | Bristol Myers Squibb Canada Inc. | 2021-10-29 | 105 |
*Time to Initiation (TTI) – Time between ‘final recommendation issued to sponsor and drug plans’ and ‘pCPA Engagement Letter Issued’
Signals Decoded:
While the pCPA initiated negotiations for 6 products in October, the total number of files under active negotiation decreased for the third month in a row (33) as a result of 8 negotiations concluding with an LOI.
The files initiated in October were split evenly between oncology and non-oncology. The pCPA initiated negotiations on the same day for Jorveza for 2 different but closely related indications, one of which had been under consideration for 359 days, signalling that pCPA likely waited for both indications to have CADTH recommendations to engage at once.
Completed Negotiations:
The pCPA completed 8 negotiations with a Letter of Intent (LOI) in October 2021, up from 7 in September.
| PRODUCT | INDICATION | Sponsor | Status | LOI DATE | TTN* |
|---|---|---|---|---|---|
| Non-Oncology | |||||
| Mayzent (siponimod) | Secondary Progressive Multiple Sclerosis (SPMS) | Novartis Pharmaceuticals Canada Inc. | Completed | 2021-10-22 | 178 |
| Zolgensma (onesemnogene abeparvovec)** | Spinal muscular atrophy (SMA), pediatrics | Novartis Pharmaceuticals Canada Inc. | Completed | 2021-10-08 | 231 |
| Oncology | |||||
| Calquence (acalabrutinib) | Chronic Lymphocytic Leukemia (CLL) (previously untreated) | AstraZeneca Canada Inc. | Completed | 2021-10-05 | 131 |
| Calquence (acalabrutinib) | Chronic Lymphocytic Leukemia (CLL) | AstraZeneca Canada Inc. | Completed | 2021-10-05 | 131 |
| Venclexta (Venetoclax) | Chronic Lymphocytic Leukemia (CLL) | AbbVie Corporation | Completed | 2021-10-13 | 232 |
| Tecentriq & Avastin (Atezolizumab & Bevacizumab) | Hepatocellular Carcinoma (HCC) | Hoffmann-La Roche Limited | Completed | 2021-10-14 | 202 |
| Biosimilar | |||||
| Riabni (rituximab) | Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangitis (GPA), Microscopic Polyangitis (MPA) | Amgen Canada Inc. | Completed | 2021-10-14 | 125 |
| Abevmy (bevacizumab) | Metastatic colorectal cancer (mCRC), locally advanced, metastatic or recurrent non-small cell lung Cancer (NSCLC), platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer, and glioblastoma | BGP Pharma ULC | Completed | 2021-10-25 | 136 |
* TTN = Time to Negotiate in calendar days
**Cell and Gene Therapy
Closed Negotiations:
The pCPA did not close any negotiations without an LOI in October 2021.
Not Negotiated:
The pCPA did not decline any negotiations in October 2021.
Signals Decoded:
The pCPA concluded 8 negotiations with an LOI in October – 1 non-oncology, 4 oncology, 2 biosimilars, and 1 gene therapy. The biosimilars (rituximab and bevacizumab) are both the fourth versions to have concluded pCPA negotiations. The oncology product Calquence completed two negotiations for similar indications under identical timelines (131 days) while their CADTH recommendations were separated by 2 months.
Zolgensma, a high-cost one-time gene therapy for spinal muscular atrophy, completed pCPA negotiation after having been initiated prior to a final CADTH recommendation (only the INESSS recommendation had been published).
Signals Decoded:
The overall volume and average negotiation time of files continues to trend at levels seen throughout 2021.
The number of files under consideration for greater than 6 months (8) and the number of files under active negotiation for greater than 12 months (1) remained unchanged from September.
The total number of files adjudicated by the pCPA remains higher than usual at 8, following highs of 10 (August) and 9 (September).
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